This was a cohort study that compared baseline and follow-up values in type 2 diabetes patients undergoing an intervention; this study lacked a comparison group. This study was conducted in Matsumoto City, Nagano Prefecture, Ibaraki City, Osaka Prefecture, Shimanto City, Kochi Prefecture, Tama City, Tokyo, and Tachikawa City, Tokyo, from April 2017 to March 2020. The follow-up period was six months. The target patients were diagnosed with type 2 diabetes and chronic kidney disease grade ≥ 3 (eGFR of ≤ 30 mL/min/1.73 m2). Eligible patients were identified by attending physicians based on the relevant criteria and willingness to participate. The exclusion criteria were as follows: (1) severe diabetic complications, and (2) diagnosis of dementia, psychiatric disorder, or cancer. The variables of interest included age, sex, BMI, HbA1c levels, eGFR, blood pressure values, target achievement rate, medication adherence rates, and self-efficacy scores. Blood pressure was expressed as systolic and diastolic blood pressure.
Enhancing self-efficacy helps promote self-care and disease management in patients with type 2 diabetes [13]. Improved self-efficacy is among the goals of patient education provided by community pharmacists. Few tools to measure self-efficacy in patients with type 2 diabetes are available; the DMDSES is useful for the assessment of specific dietary efforts [14] and complements the development of related scales [15, 16]. Therefore, the DMDSES was used as an evaluation index in the M*Adhere Motivational Interactive Program (m-MIP)(R)[3]. The DMDSES has a perfect score of 75 points.
In this study, BMI, HbA1c, eGFR, target achievement rate, medication adherence rate, and the DMDSES value were compared at baseline and at follow-up.
Diabetic microangiopathy, nephropathy, neuropathy, and retinopathy are caused by persistent hyperglycaemia. To control the onset of microangiopathy, blood glucose levels need to be closer to normal, and the short-term goal is HbA1c < 7.0%, which is a value recognized as borderline for the prevention of microangiopathy [4, 17]. Separate analyses were performed because lowering HbA1c in patients with HbA1c 7.0%≤ is particularly important.
Self-management coaching program (m-MIP)
In this program, general practitioners and phaemacists at community pharmacies work together to promote changes in patient behaviour. Patients, enrolled in the programme by their physician, receive a lifestyle improvement plan from a pharmacist at an insurance pharmacy that is to be implemented over a period of six months. This programme aims to improve diet, exercise, and medication adherence. The pharmacist coaches the uptake of the programme by providing education and helping to remove barriers to behaviour change. Specifically, the programme includes the following components: 1) a pharmacist at an i community pharmacy receives training on diabetes research and coaching skills from M*Adhere Inc., 2) the pharmacist provides guidance to patients enrolled in the programme, 3) patients submit food diaries to their pharmacists who forward them to registered dieticians for evaluation that informs further guidance, 4) the pharmacist creates a coaching report with relevant instructions, 5) a pharmacist certified by the Board for Diabetes Educators evaluates the coaching report and provides feedback to the community pharmacist, and 6) the community pharmacist provides interim patient status updates to the physician who developed lifestyle improvement plan. These are evaluated based on a case review method, accounting for living conditions, medication status, and dietary evaluation, among others. Prescriptions are changed, as required.
Statistical analysis
Normally distributed variables are presented as means ± standard deviations. Categorical variables were analysed using the Fisher exact and chi-square tests and are expressed as counts or percentages. Findings were considered statistically significant at p-values of < 0.05. All statistical analyses were performed using the IBM SPSS Statistics for Windows, version 25.0 (IBM Corp., Armonk, NY).
Ethical considerations
This study was conducted in accordance with the ethical guidelines for medical and health research involving human subjects. The Ethics Board of the Justavia approved the study (Control number: 2020010). Justavia is a medical corporation located in Tokyo, Japan. This study is conducted by obtaining information that anonymized patient information by M* Adhere Inc. Because unlinked, anonymized data were used, The Justavia Ethics Review Board confirmed that this study was not subject to compliance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects. The Justavia Ethics Review Board waived the need of informed consent.